Clearance Summary
BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge received FDA 510(k) clearance under submission number K232393, sponsored by Proedge Dental Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-10-27.
- Submission: K232393
- Applicant / Sponsor: Proedge Dental Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2023-10-27
Classification & Regulation
This clearance is catalogued under FDA product code QYJ and 21 CFR 872.6640, within the Dental review panel as a Class I device.